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FDA Reluctantly Admits Mercury Fillings Have
Neurotoxic Effects on Children
For the first time, the FDA has issued a warning that the mercury
contained in silver dental fillings may pose neurological risks to
children and pregnant women.
"Dental amalgams contain
mercury, which may have neurotoxic effects on the nervous systems of
developing children and fetuses," reads a statement that has been added
to the agency's Web site. "Pregnant women and persons who may have a
health condition that makes them more sensitive to mercury exposure,
including individuals with existing high levels of mercury bioburden,
should not avoid seeking dental care, but should discuss options with
their health practitioner."
The warning was one of the conditions that the FDA agreed to in settling
a lawsuit filed by several consumer health groups.
"Gone, gone, gone are all of FDA's claims that no science exists that
amalgam is unsafe," said Charles Brown, a lawyer for Consumers for
Dental Choice, one of the plaintiffs.
"It's a watershed moment," said Michael Bender of the Mercury Policy
Project, another plaintiff.
Mercury is a well-known neurotoxin that can cause cognitive and
developmental problems, especially in fetuses and children. It can also
cause brain and kidney damage in adults.
So-called dental amalgams, or fillings made with a mix of mercury and
other metals, have been used since the 1800s. Although it is known that
small amounts of mercury are vaporized (and can be inhaled) when the
fillings are used to chew food, and though Canada, France and Sweden
have all placed restrictions on the use of mercury fillings, the FDA has
always insisted that amalgams are safe.
Dental amalgams are considered medical devices, regulated by the FDA.
Even the FDA's new warning stops short of admitting that dental amalgams
are dangerous for the general population. Instead, it focuses on the
same population that has already been warned to limit mercury exposure
by consuming less seafood: children and pregnant women. The FDA says it
does not recommend that those who already have mercury fillings get them
removed.
Millions of people have received amalgam fillings, although their
popularity has dropped off in recent years. Currently, only 30 percent
of dental fillings contain mercury - the rest are tooth-colored resin
composites made from glass, cement and porcelain. These alternative
fillings are more expensive and less durable than amalgam, however.
In 2002, the FDA began a regulatory review of amalgam that was expected
to be complete within a few years. In 2006, with the review still
incomplete, an independent FDA advisory panel of doctors and dentists
rejected the agency's position that there is no reason for concern about
the use of amalgam. While the panel agreed that the majority of people
receiving such fillings would not be harmed, panel members expressed
concern for the health of certain sensitive populations, including
children under the age of six.
The panel recommended that the FDA conduct further studies on the risks
to children from dental amalgam, and that it consider a policy of
informed consent for children and pregnant: that is, warning those
groups of the risks associated with the fillings before installing them.
Part of the lawsuit centered on the FDA's failure to respond to these
recommendations in a timely fashion.
"This is your classic failure to act," federal judge Ellen Segal Huvelle
told the agency.
As part of the lawsuit settlement, the FDA must reach a final decision
on the regulation of amalgam by July 28, 2009.
"This court settlement signals the death knell for mercury fillings,"
Brown predicted.
But J.P. Morgan Securities analyst Ipsita Smolinski disagreed, saying
that the FDA is unlikely to ban amalgam entirely
"We do believe that the agency will ask for the label to indicate that
mercury is an ingredient in the filling, and that special populations
should be exempt from such fillings, such as: nursing women, pregnant
women, young children, and immunocompromised individuals," Smolinski
said.
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